REGISTRATION

11678-72 
Material Sent for Data Extraction 

Reg. # -----f/'--L1.£.6~1f"---~;::'__"· ::.G/=--__ 

Description: _____________ _ 

D Material(s) Sent to Data Extraction Contractors: 

New Stamped Label Dated £:d. /? olCl/ I , 

Notification Dated ____ _ 

D New CSF(s) Dated ____ _ 

D Other: __________ _ 

D Decision #: ______ _ 

D Other Action/Comments: ________ _ 

File this coversheet and attached materials in the jacket. It must be 

well organized and clipped together, NOT STAPLED. Then give the 

jacket with the coversheet and materials to staff in the Information 

Services Center (ISC) (Room 5-4900). If a jacket is full or only 

available as an image, please file materials in a new jacket and bring it 

down to the (ISC). For further information please call 703-605-0716. 

Reviewer: r&t0 ~ 

Phone:?f?3,3(l([- S~t? r 

Date: 4¥CI('/ 

Division: -,',;0,~d,,-,-___ _ 

1
~,,£o sr~1: " '. EPA Reg. Date of Issuance: f ft '~ 

.~~~ Number: 

~ , '. 1-'1~ f'RCiI~c} ~ U.S. ENVIRONMENTAL PROTECTION AGENCY 11678-72 

Office ofPestieide Programs 

Registration Division (H7505P) Tenn of Issuance: Conditional 

1200 Pennsylvania Avenue NW Name of Pesticide Product: 

Washington, D.C. 20460 

MCW Technical 

NOTICE OF PESTICIDE: 

Diflubenzuron 

L Registration 

_ Reregistration 

(under FIFRA, as amended) 

Name and Address ofRegistran£ (include ZIP Code): 

Ms. JenniferYentel 

Makhteshim Chemical Works, Ltd. 

c/o Makhteshim Agan of North America, Inc. 

4515 Falls of Neuse Rd., Suite 300 

Raleigh, NC 27609 

Note: Changes in labeling diffcriIlg In substance from that accepted in connection with this registration must be submiltcd to and acccpted by the 

Registralion Division prior to use of the label in commerce. In any correspondence on this product always refer to the above EPA registrationnumbcr, 

On the basis of information furnished by the registrant, the above named pesticide is hereby registered/reregistered under the Federal insecticide, 

Fungicide and Rodenticide Act. 

Reg'tstration is in no way to be construed as an endorsement or recommendation of this product by the Agency. In order to protect health and the 

environment, the Administrator, on his motion, may at any time suspend or cancel the registration of a pesticide in accordance with the Act, The 

acceptance of any name in connection with the registrntion of a product under this Act is not to be construed as giving the registrant a right to exclusive 

use of the name or to its use if it has been covered by others. 

This product is conditionally registered in accordance with FlFRA sec. 3(c)(7)(A). Oncea 

pesticide is registered, however, it is not regarded as pennanently acceptable. Registration does not 

eliminate the need for continual reassessment of pesticides. If the Agency detennines that, at any 

time, additional data are required to maintain in effect an existing registration, the Agency will 

require submission of such data under FIFRA section (3)(c)(2)(B). 

1. Revise the EPA Registration Number to read, EPA Reg. No. "11678-72". 

:~,'~ ;~~g~~v ~ 0'1<: 

OCT 1 22011 ~ AoHng Pmd"" M,n'g" (I) 

Insecticide-Rodenticide Branch 

Registration Division (7504P) 

EPA Fonn 8570-6 

2
Page Two 

11678-72 

2. Submit two copies of your final printed label before you release the product for 

shipment. If these conditions are not complied with, the registration will be subject to 

cancellation in accordance with FJFRA section 6(e). Your release for shipment of the product 

constitute acceptance of these conditions. 

A stamped copy of the label is enclosed for your records. If you have any questions 

regarding this notice contact Dani Daniel at 703 305~5409. 

Enclosure 

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MCW TECHNICAL DIFLUBENZURON 

ACTIVE INGREDIENT: % BY WT. 

Diflubenzuron N-[[(4-chlorophenyl)aminolcarbonyl]-2,6-difluorobenzamide ........................ 97.9% 

OTHER INGREDIENTS: ...................................................................................................... 2.1 % 

TOTAL: 100. 0% 

ACCEPTED 

OCT 1 2 2011 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

Under the Federal Insecticide. Fungiclda. 

and Rodenticide Act as amended for.the Manufactured for: . . ~ ~ M'aRhteshlm Chemical Works, Ltd. 

pestiCide regIStered undlllio Makhteshim Agan of North America, Inc. 

//re 11 7," 4515 Falls of Neuse Rd., Suite 300 

EPA. Reg. No: ,J' - ~.u Raleigh, NC 27609 

EPA Reg. No. 11678·XJ(x EPA Est. No. 

NET CONTENTS: ___ Ibs 

FIRST AID 

IFON SKIN OR • Take off contaminated clothing. 

CLOTHING: • Rinse skin immediately with plenty of water for 15 to 20 minutes. 

• Call a poison control center or doctor for treatment advice. 

EMERGENCY ASSISTANCE: Have the product container or label with you when calling a poison control 

center or doctor, or going for treatment. You may contact Prosar at 1-877-250-9291 for emergency 

medical treatment information. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

CAUTION: Harmful if absorbed through skin. Avoid contact with eyes, skin or clothing. Wash hands 

before eating, drinking, chewing gum, using tobacco or using the toilet 

ENVIRONMENTAL HAZARDS 

Do not discharge effluent containing this product into fakes, streams, ponds, estuaries, oceans or other 

waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System 

(NPDES) permit and the permitting authority has been notified in writing prior to discharge. PPc not 

discharge effluent containing this product to sewer systems without previously notifying the local<s~e:,'-r@ge 

treatment plant authority. For guidance contact your State Water Board or Regional Office of the f-Pp,-.., 

, , DIRECTIONS FOR USE ' , , , 

It is a violation of Federal law to use this product in a manner inconsistent w·rth lts labctllrig: ~ , < < < 

Only for formulation into an insecticide growth regulator for the following USeS: ' , : ' < < :' , < 

(1) artichokes, barley, oats, triticale, wheat, citrus, cotton, grassland, leafy brassica ar;(3! <turr::ip 

greens, mushrooms, peanuts, pears, peppers, rice, soybeans, stonefruit (toJi.cluping cherrieG), 

treenuts, turigrass, bolus, feed-through and premise treatments for fly corlb'ul, 'non-food uses: 

omamentals, forestry, products for parasite control in ornamental fish ponds, wood ;0T, '«ftJpd 

structure protection treatments, i.e. termite bait stations; aquatic non-crop sites: e.g. proUucts for 

mosquito/midge control. : , , , ; , 

(2) uses for which U.S. EPA has accepted the required data and/or citat"lons of dataL that the 

formulator has submitted in support of registration; and 

(3) uses for experimental purposes that are in compliance with U.S. EPA requirements. 

4
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This product is fOf use only by formulators in the manufacture of agricultural insecticide growth regulator 

products, offered for sale to the public, and which are duly registered with the Environmental Protection 

Agency, Washington D.C. Formulators using this product are responsible for obtaining EPA registration 

for their formulated product(s). 

STORAGE AND DISPOSAL 

Do not contaminate water, food or feed by storage or disposal 

PESTICIDE DISPOSAL: Pesticide, spray mixture, or rinsate that cannot be used or chemically 

reprocessed should be disposed of in a landfill approved for pesticides. 

PESTICIDE STORAGE: Store the product in a dry, cool and ventilated place. 

CONTAINER DISPOSAL: Nonrefillable container. Do not reuse or refill this container. Offer for 

recycling, if available or dispose of liner in a sanitary landfill, by incineration or if allowed by State and 

local authorities, by buming. If burned, stay out of smoke. If drum is contaminated and cannot be 

reused, dispose of in a manner required for its liner. 

GENERAL: Consult Federal, State or Local disposal authorities for approved alternative procedures. 

LIMITATION OF WARRANTY AND LIABILITY 

Read the entire directions for use, conditions of warranties and limitations of liability before using this 

product. If terms are not acceptable, return the unopened product container at once. 

By using this product, user or buyer accepts the following CONDITIONS, DISCLAIMER OF 

WARRANTIES, and LIMITATIONS OF LIABILITY. 

CONDITIONS: The directions for use of this product are believed to be adequate and must be followed 

carefully. However, it is impossible to eliminate all risks associated with the use of this product. Crop 

injury, ineffectiveness, or other unintended consequences may result because of such factors as weather 

conditions, presence of other materials, or the manner of use or application, all of which are beyond the 

control of Makhteshim Chemical Works, Ltd. All such risks shall be assumed by the user or buyer. 

DISCLAIMER OF WARRANTIES: To the extent consistent with applicable law, Makhteshim Chemical 

Works, Ltd. makes no other warranties, express or implied, of merchantability or of frtness for a particular 

purpose or otherwise, that extend beyond the statements made on this label. No agent of Makhteshim 

Chemical Works, Ltd. is authorized to make any warranties beyond those contained herein or to modify 

the warranties contained herein. To the extent consistent with applicable law, Makhteshim Chemical 

Works, Ltd. disclaims any liability whatsoever for special, incidental or consequential damages resulting 

from the use or handling of this product. 

LIMITATIONS OF LIABILITY: To the extent consistent with applicable law, the exclusive remedy of the 

user or buyer for any and all losses, injuries or damages resulting from the use or handling of this 

product, whether in contract, warranty, tort, negligence, strict liability or otherwise, shall not exceed the 

purchase price paid or at Makhteshim Chemical Works, Ltd.'s election, the replacement of product. 

Mew Diflubenzuron Technical (11678-xxx) 00 EPA 09-23-11) 

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21-Day Screen Completed by 

Contractor 

21-Day Expires on 10 -It-II 

Jacket # / /~ 7% -1£ 

• 

MRID# ___ _ 

. \ 

Content Screen: Recommend to~aiI 

86-5 Review: PasslFai~ 

Overall Status: Recommend t~ail 

Transfer This Jacket to: 

(JfVI- / > 

--

6
PRIA 2 - 21 Day Content Screen Review Worksheet 

(EPNOPP Use Only) 

3/23/09 

21 Day Screen Start Date: ___ -'9''---'2'-'-7_-fl-'.I ______ ___=_ 

Experts In~Processing Signature: , .r7 /" /.hA.A.M"arlW Date 9- 2';--1/ Fee Paid: Yes Y 

Division management contacted on issues No Yes Date 

EPA Reg. Number: If C, 7 fr - T EPA Receipt Date: ~ - 27- If 

Items for Review Yes No N/A* 

1 

2 

3 

4 

5 

Application Form (EPA Form 8570-1)(link to form) signed & complete 

including package type 

Confidential Statement of Formula all boxes completed, form signed, and 

to 

a) All inerts (link to http://www.epa.gov/opprdOOl/inerts/), 

including fragrances, approved for the proposed uses (see 

Footnote 

Certification with Respect to Citation of Data (EPA Form 8570-34) (Link to 

fonn) completed and signed (N/A if 100% repack) 

Certificate and data matrix consistent 

If applicant is relying on data that are compensable, is the offer 

to pay statement included. (see Footnote B) 

yes 

completed and "5'''OU (N/ A if source is unregistered or applicant owns the 

no 

Data Matrix (EPA Form 8570-35) (Link to fonn) both internal and external 

copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A if 100% 

Selective Method 

b) Cite-All (Fee category experts use) 

c) Applicant owns all data (Fee category experts use) 

x 

5 Copies of Label (link to http://www.epa,gov/oppfeadlllabelingllrmD 

6 (Electronic labels on CD are encouraged and guidance is available)( link to Y 

http://www.epa.gov/pesticides/reguJatingiregistering/submissions/index.ht m#lab eJ s / \ 

1 

x 

x 

7
7 Is the data packa2e consistent with PR Notice 86-5 (link to PRN 86-5) ~ 

Notice of Filing (link to 

8 httQ:llwww.eQa.gov/Qesticides/regulatin2/tolerance Qetitions.htm) included x: with petitions (link to 

http://www.epa.gov/pesticides/regulatingltolerances.htm) 

9 If applicable for conventional applications, reduced risk rationale (link to 

http://www.epa.gov/opprdOOl/workplan/reducedrisk.html) X 

Required Data (link to 

httQ:llwww.eQa.govluesticides/regulatin2/data reguirements.htm) and/or 

data waivers. See Footnote C. 

a) List study (or studies) not included with application 

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10 

2 

8
Comments: 

r.J 1f)C'r--fs. -- (00 % re pc.. C.(L, Ill> ~fler+.s. --b re.V!e:t-v 

"'J DoCt{vt.. -e /L+'" -f,,,,,: f t:;.<>:;' 

* N/A - Not Applicable 

Footnotes 

A. During the 21 day initial content review, all eSFs will be reviewed to determine 

whether all inerts listed, including fragrances, are approved for the proposed uses. If an 

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for 

example, removing the inert, substituting it with an approved inert, submitting 

documentation that EPA approved the inert for the proposed pesticidal useS, correcting 

mistakes on the eSF, etc. or 2) provide the data to support OPP approval of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

eSF and may require submission of data. All infonnation. fonns. data and 

docwnentation resolving the inert issue must have been received by the Agency or the 

application withdrawn within the 21 day period. otherwise. the Agency will reject the 

application as described below. 

To successfully complete this aspect of the 21 day initial content screen, applicants are 

strongly encouraged to verify that all inert ingredients have been approved for the 

application's uses even if a product is currently registered by consulting the inert Web 

3 

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site [link to http;//www.epa.gov/opprdOOl/inertsllists.html] and if the inert is not 

approved, to obtain the necessary inert approval prior to submitting an application 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

andlor CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inert ingredient web site and the applicant believes that the 

inert has been approved, the applicant should contact the Inert Ingredient Assessment 

Branch (IIAB) at inertshranch@epa.gov and resolve the issue. Copies of the 

correspondence with lIAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by IIAB. The lIAB should also be contacted 

for any questions on what supporting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdllbiopesticides/contactsbppd.htm]. 

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, 

additional information such as an alternate name of the inert, CAS number or other 

information [link to http://www.epa.gov/opprdOOllinerts/tips.pdt] must also be included 

to enable the Agency to determine if it has been approved. Each component of an inert 

mixture (including a fragrance) must be identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants must arrange with a proprietary mixture or 

fragrance supplier to provide the component information to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21-day content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit information to the individual 

identified by the Agency when the applicant is informed of an unapproved inert. 

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified on a CSF, the Agency will contact the 

applicant with the following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If this option is selected and implemented, the Agency may 

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

4 

10
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R313), it will contact the applicant with the 

following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses;:-or 

2. Submit the infonnation and data needed for the Agency to approve the 

unapproved inert, including any required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21-day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF and a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

1. Correct the application by, for instance, correcting the spelling or name of the 

inert to that in 40 CPR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the infonnation and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. If this option is selected and implemented, the 

Agency will discuss harmonizing the timeframe for both actions. 

5 

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3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B, A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R30 1 or 

A53!. The Agency recommends that authorizations of offers to pay be submitted with 

other PRIA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency, Documentation of such discussions 

should be submitted with the study waiver. 

6 

12
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

September 28, 2011 

OPP Decision Number: D-455479 

EPA File Symbol or Registration Number: 11678-TE 

Product Name: MCW DIFLUBENZURON TECHNICAL 

EPA Receipt Date: 27-Sep-2011 

EPA Company Number: 11678 

Company Name: MAKHTESIDM CHEMICAL WORKS LTD 

CHUCK LEVEY 

MAKHTESIM-AGAN OF NORTH AMERlCA, INC. 

MAKHTESIDM CHEMICAL WORKS LTD 

4515 FALLS OF NEUSERD, SUlTE 300 

RALEIGH, NC 27609-

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application and certification of 

payment. If you submitted data with this application, the results of the PRN-86-5 screen will be 

communicated separately. During the administrative screen, the Office of Pesticide Programs 

has determined that this Action is subject to a Pesticide Registration Service Fee as defined in 

the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R300 

NEW PRODUCT;ME-TOO PRODUCT FAST TRACK; 

No additional payment is due at this time. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Sincerely. 

~:::::z.L 

Front End Processing Staff 

Information Technology & Resources Management Division 

13
IFee for Servicel 

This package includes the following for Division 

Cil New Registration °AD 

°Amendment °BPPD 

Cil RD 

o Studies? o Fee Waiver? 

o volpay % Reduction: 

Risk Mgr. 

Receipt No. s-I 904050 

EPA File Symbol/Reg. No. I 11678-TE 

Pin-Punch Date: I 9/27/2011 

o This item is NOT subject to FFS action. 

i 

(904050iIT] 

I 

I 

I 

. . ParenVChild Decisions: 

Requested: 1'4-3 Ob I 

Granted: I e-> (Ji) I 

Amount Due: $ ;L{3({Ob 

to Intended Use D Uncleared Inert in Product 

Date: 7 k //; ( , Reviewer:._--II-l.L'.--'d,L-"""'-'---"'---___ _ 

Remarks: 

14
( 

R 300 and 301 

100% identical [repack):!ffi'or NO [circle onel 

{If yes, it's a 100% repach""n product chemistry, acute toxicity and efficacy data 

are not required} 

Data on Group and A and B must be submitted - Group A and B can not be cited. 

Data 

Guideline Group A: Product Chemistry Data submitted 

No. Study Title Yes No 

830.1550 Product Identity & Composition 

Description of materials used to produce the 

830.1600 product 

830.1650 Description of formulation process 

830.1670 Discussion on the formation of impurities 

830.1700 preliminarv analvsis 

830.1750 Certified limits [158.3451 

830.1800 Enforcement analytical method 

Data 

Guideline Group B: Product Chemistry Data submitted 

No. Study Title Yes No 

830.6302 Color 

B30.6303 Physical state 

830.6304 Odor 

Oxidation/Reduction [Chemical 

830.6314 incompatibility) 

830.6315 Flammability 

830.6316 Explodability 

830.6317 storage stability 

830.6319 Miscibility 

830.6320 Corrosion Characteristics 

B30.6321 Dielectric Breakdown YoltaQe 

830.7000 pH 

830.7100 Viscosity 

830.7300 Density 

1 

15
( 

R 300 and 301 

, 

, 

New products must provide a bridging rationale document. The bridging document 

directs OPP to use a currently registered set of 6 acute toxicity data and label; instead 

of submitting product specific data. 

Guideline Acute toxicity (6 pack) Cited 

No. study Title Yes No 

870.1100 Acute Oral (LD50) 

870.1200 Acute Dermal ILD501 

870.1300 Acute Inhalation (LC50) 

870.2400 Acute Eye Irritation 

870.2500 Acute Dermal Irritation 

870.2600 Dermal Sensitization 

Efficacy - which guideline depends on the proposed label use and they must cite the 

data to be used for the bridging rationale. 

Guideline Cited 

No. Efficacy Study Titles Yes No Comments 

810.3100 Soil Treatments for Imported Fire Ants 

Livestock, Poultry, Fur and Wool-8earing 

810.3200 Animal Treatments 

Treatments to Control Pests of HUmans 

and 

810.3300 Pets 

Mosquito, Black fly, and Biting Midge 

810.3400 (Sand fly) Treatments 

810.3500 Premises Treatments 

810.3600 structural Treatments 

Methods for Efficacy Testing of Termite 

810.3800 Baits 

2 

16
Regulatory Type: lpro~_uct ,Re~i~ratiOfl ~ Se~on 3 _=~l fee for ,Service: 'C-~-',-~"~ '. ----'--"''' 

Application Type: l.~e~. R,:~str.atl~. .; '=;J, ' ,BHiable: 

CompanY: ~}~:~~w 'i)ll1/l,KHTESHIM CH~ICA~ W<?RK~,L TD ,_ ,,·r.·._., _._,, __ .'_ ,_",. "_ "'."._ 

Risk Manager: I~e~~~~~on ~iv~si~, R,is,k_ ¥~n~ge~ent, Te'~~_ ~,,;, _''r 

r Yr:,", r. 

r-f{esi . , . r 

r. Yos r 

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No 

r·c+c ... ~ .. --'C'--~I 

i Print letter , , I ' i' Enter More Informtrtion I 

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Product#: \~16182tf," --\ I Producf Name: P?:,pll~:~~Z,U~~}~C~I(:;~" 

,Overricie;¥, L >., _ ' 

Me To~ ,< - , ,-'. ,- SectionS; "

Appf!Cliltion ~ale: 123-sep-2011 i!d I 

front Eljd' Date:: '-127 ~S~p_2011 - !.WI 

" fF-O OUe Date: L~- ,-,-

'opp Target Date: r-" 

CpP Rec'vd Date: ]27-sep-2011_ ~I 

Risk Manager Send Date: 1 'l!2Il 

NegoI:latedDueDate'. rl~~~~ 

" F'i5t Jre.ck; r 

Receipt "DescriPtion: 

New Ingrelilent. r" View/Edit 

o register a 100% repackage of a registered technical product NeVi Jngrefil<:'fll l r ~----, 

F."e-quiSd Dale: .. ', 

I J2W Ingredient "I ~-~-­

Received Oale-' 

SiDn:;IUI''; DblE: I .. , .. 

.~~I 

17 *Product ingredient source information may be entitled to confidential treatment*
Jennifer Yentel 

From: 

Sent: 

To: 

Subject: 

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paygovadmin@maiLdoc.twai.gov 

Monday, September 19, 2011 10:46 AM 

Jennifer Yentet 

Pay.Gov Payment Confirmation 

THIS IS AN AUTOMATED MESSAGE. PLEASE DO NOT REPLY. 

Your transaction has been successfully completed. 

Transaction Summary 

Application Name: PRIA Service Fees 

Pay.gov Tracking ID: 254FHGHS 

Agency Tracking 1D: 74238706238 

( 

Name On Account: Makhteshim Agan of North America Transaction Type: ACH Debit Transaction 

Amount: $l,434.0e Payment Date: Sep 2a, 2811 Account Type: Business Checking Routing Number: 

Account Number: ************7618 

Transaction Date: Sep 19, 2811 18:45:38 AM Number of Payments Scheduled: 1 

Frequency: OneTime 

Decision Number: 

Registration Number: 11678-

Company Name: Makhteshim Chemical Works 

Company Number: 11678 

Action Code: R300 

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18 *Commercial/financial information may be entitled to confidential treatment*
PI •••• r •• dlm ru ( ·OM on rtlv.,.. "forti L 4etifJJI. form. ( Flilrm A~~I OMELNo. tQ]O-QORI" • '·28·95 

Unitad Statas ~ Registration OPP Identifier Number 

&EPA Environmental Protection Agency Amendment 

Woshington, DC 20460 Other 

Application for Pesticide - Section I 

I. companV(Prod~e Number 2. EPA Product Manager 3. Proposed Classification 

11678·XXX 1 Kable Bo Davis l!jNone o Restricted 

4. CompanvlProduct (Name! PM. 

MeW Diflubenzuron Technical 25 

5. Nama and Address of Applicant (Iflcludll ZIP CodllJ 6. Expedited Reveiw. In accordance with F!FRA Section 3{c)(3) 

Makhleshim Chemical Works, Ud. (blli), mv product is similar or identical in composition and labeling 

clo Makhteshim Agan of North America, Inc. to: 

4515 Falls of Neuse Rd., Suite 300 EPA Reg. No.

RaleiQh. NC 27609 o Chllck if rhis is I!I fllIW sddrlltiS Product Nam

Section - II 

0 Amandment - Explllin below. U Final printed laba!s in rapsonso to 

Agencv lettar dotad 

0 Resubmission in rasponsa to Agencv letter dated [2] "M9 Too· Appftcation. 

0 Notificalion - Explain below. 0 Othar - Explllin below. • 

Explanation: Uso edditionlll pagels) if necessary. (For section rand Saction II.! 

Application to register a 100% repackage of a regislered technical product. 

Fee Category: R300 

Fee Due: $1 ,434 

The PRIA fee has been paid on-line at www.pay.gov. A copy of the electronic confirmation is attached. 

E-mail: jyentel@manainc.com 

Section - III 

1. Materiel Thi_ Product Will Sa Packeged In: 

Child·Resistanl Packaging Unit Pockllging Wator Soluble Pockaging 2. Typo of Container 

tZl v

" @v., B V" 

.f N. .f N. ~M"" of Pfastic N. Gloss 

• Certification must If ·Yas· No. per !f "Yes" No. per PaplIl 

Unit Packaging wgt. container Peckage wgt container Other (Specify! bs submftttHI 

I 

3. location of Net Centants Infolmation 4. Siza(s) Retail Containllr 5. location of lobal Oirections 

[{J labal U Container 55 Ib - bulk t::::=::j On lobel 

On labeling accomponylng pteduci 

0 ' , < ( 

6. Manner in Which label is Affixed to Product o lithograph Other • • 

of Pllpar ~'ued '""'""-'---

Stonci lid • .. -~ Section - IV 

" 

'(, , 

, " 1. Contact Point (Comp/ore ifllms dirllclly below for id(Jfltificatiofl of ifldividueJ fo be contllcflld, if flIICD$Sary, ro pcoctnS fhis ElPP/iollriq'l.( ~-, 

Name Title 'I Tofopi;one Nd. On'clude Ailla Coda) 

Jennifer Yentel Regulatory Specialist , «9:1:9) 256-93105 : .. Certification " , " 6. Oot(. Applicatien 

r cenifV that the stotllments! hove made on this form lind ell attachments theleto are true, accurate and complate. ,Recei·Jed 

, • <, , I acknowledge thet any knowlingllv folso or misleading statement mav be punishable bv fino or imprisoNnent or (Stamped) 

both under applicllb!e law. , 

", .. , 

2. Signature 3, Title 

q'!-~", r' &L Regulatory Specialist 

4. Typed Nama 5. Doto 

Jennifer Yentel 09·23·2011 

.. EPA Form 8570·' (Rev. 3-94) PreVIous adltlons lire obsolete. White - EPA fik, Copy (origin.'j YeDow • App&cant Copy 

19 *Product ingredient source information may be entitled to confidential treatment*
[t] 

MANA 

September 23, 2011 

Document Processing Desk {REG FEE} 

Office of Pesticide Programs (7504P) 

u.s. Environmental Protection Agency 

Room 5-4900, One Potomac Yard 

2777 S. Crystal Drive 

Arlington, VA 22202-4501 

( 

Attention: 

Phone: 

Kable Bo Davis, Registration Division, Herbicides Branch (PM Team 25) 

703-306-0415 

RE: Application to Register a Currently Registered Active Ingredient - 100% Repack 

Mew Diflubenzuron Technical (EPA File Symbol 11678-xxx) 

PRIA Category R300; $1,434; 3-month review 

Dear Mr. Davis, 

On behalf of Makhteshim Chemical Works, ltd., please find the enclosed application materials for the 

registration of MeW Diflubenzuron Technical. a manufacturing use product containing diflubenzuron as 

the active ingredient. 

In support of this application, we submit the following documents: 

1. Application for a New Pesticide Registration (EPA Form 8570-1) 

2. Receipt of PRIA pre-payment from pay.gov 

3. Confidential Statement of Formula {EPA Form 8S70-4} (2 copies) 

4. Formulator's Exemption Statement (EPA Form 8570-27) 

5. Five {5} copies of the draft labeling 

6. 

This new application for registration is for a 100% repackage of a registered technical active. This 

application falls under Category R30Q {44: New product}. As a 100% repack registration, it requires "'- '- , neither data submission nor data matrix. The fee, which has been paid, is $1,434 and the decisi60,titT1~ 

line is 3 months. ' , , , , 

,,' , 

If you have any questions or concerns regarding this applicaflon for registration, pleose:;::'o:ltact me 'at c , , , , 

your convenience at jyentel@manainc.com or {919} 256-9315. , , , , , , ~' , , ' 

Sincerely, 

91'"1+ ~ot",,\uL Jennifer Yentel 

Regulatory Specialist 

Enclosures 

4515 Falls of Neuse Road, Suite 300, Raleigh Ne 27609 

T: 919.256.9305 • F: 919.256.9308 

, 

" . " 

'" , , , 

" 

, "< 

20 *Product ingredient source information may be entitled to confidential treatment*
( ( 

Form approved. OMS No. 2070-0060, 2070-0l>¥. , 2070-0107, 2070-0122, 2070-0164. 

&EPA 

United States 

Environmental Protection Agency 

Washington, DC 20460 

Formulator's Exemption Statement 

(40 CFR 152.85) 

Appl'lC<lnfs Name and Address EPA File SymbOURegistralion Number 

Makhteshim Chemical Works Ltd. 11678-xxx 

c/o Makhteshim Agan of North America, Inc. Product Name 

4515 Falls of Neuse Rd., Suite 300 MeW Diflubenzuron Technical I] 

Raleigh, NC 27609 

Dale of Confidential Statement of Formula (EPA Form 8570-4) 

09/23/2011 

As an authorized representative of the applicant for registration at the product identified above, I certify that: 

(1) This product contains the following active ingredient(s): 

Diflubenzuron (Dimilin) 

(2) 01 these, each active ingredient listed in paragraph (4) is present solety as the result of the use of that active ingredient in the manufacturing, 

formulation or repackaging another product whjch contains that active ingredient which is registered under FIFRA Section 3, is purchased by 

us from another person and meets the requirements of 40 CFR section 158.50(e}(2) or (3). 

(3) tndicate by checking (A) or (8) below which paragraph applies: 

71 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this statement. 

That formula statement indicates, by company name, registration number, and product name, the source of the active ingredient(s) listed in 

paragraph (t). 

OR 

..., (8) The Confidentiat Statement of Formuta (CSF)(EPA Form 8570-4) referenced above and on file with the EPA is complete, current, an 

accurate and contains the information required on the current CSF. 

(4) The following active ingredients in this product qualify for the formulator's exemption. 

Source 

Active Ingredient Product Name Registrati(n '" Numller 

< ( < , 

Diflubenzuron 

( " , " , , , , , , " , , , , " , " , " , , 

" " , , , , " " . , " , " " 

, , , " , , . 

Signature Name and Title Jennifer Vente) Date 

G'L""-\r'-- Vjt1L\-bL 09/23/2011 ' , " , . Regulatory Specialist I] 

EPA Form 8570-27 (Rev. 06-2004) Copy 1 EPA 

Copy 2 - Applicant copy 

21 *Product ingredient source information may be entitled to confidential treatment*
100/", (Ct'C,,,l<.(IF> iAer-(50 -to [~v'{'C"~ ite le- 'I-t[ 

22

*Confidential Statement of Formula may be entitled to confidential treatment*